Willow, did you treat with Telaprevir in the early trials? Or are you waiting to try it still? For some reason, (maybe I have you mixed up with somebody else), I thought that you were in the trial before.
I was in Prove 3 Group C, the no Riba group and I didn't clear it by week 4. But, I don't consider myself a non-responder. I consider myself a partial responder because I had a huge drop in my viral load in week 1-2. I just rebounded because of not have the Riba in the mix.
I'd actually like to see them over us Group C people a chance to treat with all 3 drugs.
Susan
Anybody have an idea when Telaprevir might be approved for first-timers? I´m recently diagnosed HCV 1b at age 64, and probably middle-to-late-stage (nothing conclusive yet). I´d sure like to up my chances of clearing on my first time through therapy. Telaprevir could potentially save me from transplant.
Mike
Why not try and get into the phase 3 trial|?
For those interested in the PROVE 1 Study with Telaprevir there is a summary at the following link (Use must sign up to view the document).
http://clinicaloptions.com/Hepatitis/Conference Coverage/Milan 2008/Tracks/Investigational HCV/Capsules/4.aspx
Here is some of the text but I lost a lot of the formatting and all the graphic charts...Sorry
CCO Independent Conference Coverage of the 2008 Annual Meeting of the European Association for the Study of the Liver*
PROVE 1 Study: Combination Telaprevir, Peginterferon alfa-2a, and Ribavirin Therapy Has Rapid and Sustained Antiviral Activity in HCV Genotype 1 Patients
Posting Date: April 25, 2008
Randomized, placebo-controlled phase II study (PROVE 1)
Summary of Key Conclusions
* 12 weeks of telaprevir combined with 24 or 48 weeks of peginterferon alfa-2a and ribavirin produces significantly higher sustained virologic response (SVR) rates compared with 48-weeks of peginterferon alfa-2a and ribavirin in patients with genotype 1 HCV infection
* Patients achieving a rapid virologic response (RVR) may not achieve additional SVR rate increases after 24 weeks
* Higher rates of diarrhea, rash, pruritus, and anemia associated with telaprevir
* Rash associated with telaprevir more severe
* Rates of other adverse events similar to those seen with peginterferon alfa-2a and ribavirin treatment
Background:
* Telaprevir is an NS3-4A protease inhibitor of HCV in late-stage clinical trials
* Current study investigated safety and efficacy of telaprevir in combination with peginterferon alfa-2a and ribavirin compared with peginterferon alfa-2a and ribavirin alone in genotype 1 HCV patients
* Intent-to-treat analysis of all subjects completing treatment
*24-week posttreatment follow-up
Eligibility:
Inclusion criteria -
* Documented HCV infection
* Genotype 1 HCV
* Treatment naive
Exclusion criteria -
* Cirrhosis
Description of Current Analysis
Primary endpoint - SVR, defined as undetectable HCV RNA (limit of detection 10 IU/mL) 24 weeks after the end of treatment
Statistical analysis
* Intent-to-treat analysis included all randomized subjects receiving ≥ 1 dose of study drug
* Virologic breakthrough: detectable HCV DNA after achieving undetectable or > 1 log10 increase from nadir
Main Findings:
* RVR and SVR higher in the telaprevir-based treatment arms compared with 48 weeks of peginterferon alfa-2a and ribavirin alone
Patients achieving RVR with telaprevir-based treatment
* Comparable SVR rates achieved with 24 weeks or 48 weeks
* Low relapse rates observed in patients receiving telaprevir-based treatment who had undetectable HCV RNA at both Weeks 4 and 12
Among 50 patients with RVR treated > 24 weeks
* 44 completed 48 weeks
* SVR: 44 (100%)
* 6 discontinued treatment between 24 and 48 weeks
* SVR: 2 (33%)
* Relapse: 4 (67%)
Other Outcomes:
* Low rates of virologic breakthrough in telaprevir treated patients (n = 175)
* Majority occurred in first 4 weeks and in patients never achieving undetectable HCV
RNA
Week 1- 4: 5%
Week 1- 12: 7%
* Adverse events reported more frequently in telaprevir-based treatment arms than peginterferon alfa-2a and ribavirin alone
- Gastrointestinal events, skin events (rash, pruritus), and anemia
- Moderate and severe rash more frequent in telaprevir-based treatment arms
- Incidence and severity of other adverse events reported similar vs peginterferon alfa-2a and ribavirin alone
18% discontinued due to adverse events in telaprevir-based treatment arms vs 4% in peginterferon alfa-2a and ribavirin alone arm
Reference:
McHutchison G, Everson GT, Gordon SC, et al. PROVE1: results from a phase 2 study of telaprevir with peginterferon alfa-2a and ribavirin in treatment-naive subjects with hepatitis C. Program and abstracts of the 43rd Annual Meeting of the European Association for the Study of the Liver; April 23-27, 2008; Milan, Italy. Abstract 4.
Hector
Hi Mike!
"Anybody have an idea when Telaprevir might be approved for first-timers?"
Vertex says if all goes well with trials they will be applying to the FDA for new drug approval in 2011.
Hector